Drug recall
Calan SR (verapamil hydrochloride) SUSTAINED-RELEASE Caplets, 120 mg 100 count bottle, Rx only, Distributed by…
FDA recall event 58158 · Class II · Ranbaxy Pharmaceuticals, Inc.
Key facts
| Event ID | 58158 |
|---|---|
| Recall numbers | D-566-2011 |
| Recalling firm | Ranbaxy Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Calan SR (verapamil hydrochloride) SUSTAINED-RELEASE Caplets, 120 mg 100 count bottle, Rx only, Distributed by G.D. Searle LLC Division of Pfizer Inc, NY,NY 10017 NDC 0025-1901-31 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed Without an Approved NDA/ANDA: The recall is being initiated because the Pfizer manufacturing site in Caguas, PR is currently not an approved site for manufacturing Calan SR 120mg. |
| Initiation date | Mar 11, 2011 |
| Termination date | May 29, 2013 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003476632 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports